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    DRUG:

    berubicin (RTA 744)

    i
    Other names: RTA 744, Reata 744, WP744, WPD104
    Company:
    CNS Pharma, WPD Pharma
    Drug class:
    Topoisomerase II inhibitor
    Related drugs:
    2ms
    Shared and non-overlapping functions of RECQL4 and BLM helicases in chemotherapeutics-induced glioma cell responses. (PubMed, BMC Cancer)
    Our results highlight the distinct roles of RecQ helicases in a response to chemotherapeutics and support a rationale for targeting RECQL4 as a therapeutic strategy in glioblastoma.
    Journal • PARP Biomarker
    |
    RECQL4( RecQ Like Helicase 4)
    |
    Lynparza (olaparib) • temozolomide • doxorubicin hydrochloride • berubicin (RTA 744)
    7ms
    A Study of Berubicin in Adult Subjects With Recurrent Glioblastoma Multiforme (clinicaltrials.gov)
    P2, N=210, Active, not recruiting, CNS Pharmaceuticals, Inc. | Trial completion date: Mar 2025 --> Mar 2026 | Trial primary completion date: Dec 2024 --> Feb 2026
    Trial completion date • Trial primary completion date
    |
    MGMT (6-O-methylguanine-DNA methyltransferase)
    |
    doxorubicin hydrochloride • lomustine • berubicin (RTA 744)
    over1year
    A Study of Berubicin in Adult Subjects With Recurrent Glioblastoma Multiforme (clinicaltrials.gov)
    P2, N=210, Active, not recruiting, CNS Pharmaceuticals, Inc. | Trial primary completion date: Sep 2024 --> Dec 2024
    Trial primary completion date
    |
    MGMT (6-O-methylguanine-DNA methyltransferase)
    |
    doxorubicin hydrochloride • lomustine • berubicin (RTA 744)
    over1year
    A Multicenter, Study of the Safety and Pharmacokinetics of Intravenously Infused Berubicin in Pediatric Patients With Progressive, Refractory, or Recurrent High Grade Gliomas (clinicaltrials.gov)
    P1, N=0, Withdrawn, WPD Pharmaceuticals Sp. z o.o. | N=35 --> 0 | Trial completion date: Dec 2025 --> Dec 2023 | Not yet recruiting --> Withdrawn | Trial primary completion date: Dec 2025 --> Dec 2023
    Enrollment change • Trial completion date • Trial withdrawal • Trial primary completion date
    |
    berubicin (RTA 744)
    over1year
    Berubicin in Adult Patients With Recurrent Glioblastoma Multiforme (WHO Grade IV) (clinicaltrials.gov)
    P1/2, N=5, Terminated, WPD Pharmaceuticals Sp. z o.o. | N=50 --> 5 | Trial completion date: Oct 2025 --> Dec 2023 | Recruiting --> Terminated | Trial primary completion date: Oct 2025 --> Dec 2023; Business decision
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date
    |
    MGMT (6-O-methylguanine-DNA methyltransferase)
    |
    berubicin (RTA 744)
    2years
    A randomized, controlled trial of Berubicin vs. Lomustine after first-line therapy for Glioblastoma Multiforme (GBM): Interim results of a pre-planned analysis of overall survival (OS) (SNO 2023)
    Berubicin is an analog of doxorubicin (Dox) that appears to cross the BBB with significant central nervous system (CNS) uptake. The review will also include safety and secondary efficacy endpoint summaries. Results of this interim analysis will be available for the SNO annual meeting and an evaluation of its outcome will be performed, with conclusions and recommendations for the further development of Berubicin as a therapeutic option for patients with recurrent GBM.
    Clinical
    |
    MGMT (6-O-methylguanine-DNA methyltransferase)
    |
    IDH wild-type
    |
    doxorubicin hydrochloride • lomustine • berubicin (RTA 744)
    2years
    A Study of Berubicin in Adult Subjects With Recurrent Glioblastoma Multiforme (clinicaltrials.gov)
    P2, N=210, Active, not recruiting, CNS Pharmaceuticals, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    MGMT (6-O-methylguanine-DNA methyltransferase)
    |
    doxorubicin hydrochloride • lomustine • berubicin (RTA 744)
    almost3years
    Berubicin in Adult Patients With Recurrent Glioblastoma Multiforme (WHO Grade IV) (clinicaltrials.gov)
    P1/2, N=50, Recruiting, WPD Pharmaceuticals Sp. z o.o. | Not yet recruiting --> Recruiting | Trial primary completion date: Dec 2024 --> Oct 2025
    Enrollment open • Trial primary completion date
    |
    MGMT (6-O-methylguanine-DNA methyltransferase)
    |
    berubicin (RTA 744)
    over3years
    Berubicin in Adult Patients With Recurrent Glioblastoma Multiforme (WHO Grade IV) (clinicaltrials.gov)
    P1/2, N=50, Not yet recruiting, WPD Pharmaceuticals Sp. z o.o. | Trial completion date: Jan 2025 --> Oct 2025 | Trial primary completion date: Jan 2024 --> Dec 2024
    Trial completion date • Trial primary completion date
    |
    MGMT (6-O-methylguanine-DNA methyltransferase)
    |
    berubicin (RTA 744)
    over4years
    Berubicin in Adult Patients With Recurrent Glioblastoma Multiforme (WHO Grade IV) (clinicaltrials.gov)
    P1/2, N=50, Not yet recruiting, WPD Pharmaceuticals Sp. z o.o.
    Clinical • New P1/2 trial
    |
    MGMT (6-O-methylguanine-DNA methyltransferase)
    |
    berubicin (RTA 744)
    over4years
    A Study of Berubicin in Adult Subjects With Recurrent Glioblastoma Multiforme (clinicaltrials.gov)
    P2, N=210, Recruiting, CNS Pharmaceuticals, Inc. | Not yet recruiting --> Recruiting
    Clinical • Enrollment open
    |
    MGMT (6-O-methylguanine-DNA methyltransferase)
    |
    lomustine • berubicin (RTA 744)
    almost5years
    A Study of Berubicin in Adult Subjects With Recurrent Glioblastoma Multiforme (clinicaltrials.gov)
    P2, N=210, Not yet recruiting, CNS Pharmaceuticals, Inc.
    Clinical • New P2 trial
    |
    MGMT (6-O-methylguanine-DNA methyltransferase)
    |
    lomustine • berubicin (RTA 744)